Combivent Recall

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SafetyAlerts
June 6, 2002

Boehringer Ingelheim Pharmaceuticals, Inc. Has Recalled Combivent Inhalation Aerosol

The Food and Drug Administration (FDA) said Boehringer Ingelheim Pharmaceuticals, Inc. has recalled Combivent Inhalation Aerosol.

PRODUCT
Combivent Inhalation Aerosol (ipratropium bromide 18 mcg and albuterol sulfate 103 mcg) 14.7g canister, 200 metered actuations, Rx only. Recall
# D-283-2.

CODE
Lot Numbers:
165090A, Exp. Date May-03
165092A, Exp. Date May-03.

RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by FED EX on May 21, 2002. Firm initiated recall is ongoing.

REASON
Defective container; inhaler may not fire properly and patients will not receive their full dose of medication.

VOLUME OF PRODUCT IN COMMERCE
192,089 units total.

DISTRIBUTION
Nationwide.